Publications

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Displaying 1 through 14 of 14 publications.

Stothers Rosenberg S, Ng X, Mansfield C, Poulos C, Peay H, Lee TH, Irony T, Ho M. Adaptation of the WOMAC for use in a patient preference study. Ther Innov Regul Sci. 2023 Jul;57(4):702-11. doi: 10.1007/s43441-023-00510-8

Greene A, Elmer M, Ludlam S, Shay K, Bentley S, Trennery C, Grimes R, Gater A. Evaluation of the content validity and cross-cultural validity of the Study Participant Feedback Questionnaire (SPFQ). Ther Innov Regul Sci. 2020 Nov;54(6):1522-33. doi: 10.1007/s43441-020-00179-3

Hackshaw MD, Bui CL, Ladner A, Tu N, Zahidu I, Ritchey ME, Salas M. Review of survival, safety, and clinical outcomes in HER2+ metastatic gastric cancer following the administration of trastuzumab post-trastuzumab gastric cancer. Cancer Treat Res Commun. 2020;24(2020). doi: 10.1016/j.ctarc.2020.100189

Byrom B, Gwaltney C, Slagle A, Gnanasakthy A, Muehlhausen W. Measurement equivalence of patient-reported outcome measures migrated to electronic formats: a review of evidence and recommendations for clinical trials and bring your own device. Expert commentary. Ther Innov Regul Sci. 2018 Aug 29. doi: 10.1177/2168479018793369

Odom D, McLeod L, Sherif B, Nelson L, McSorley D. Longitudinal modeling approaches to assess the association between changes in 2 clinical outcome assessments. Ther Innov Regul Sci. 2018 May;52(3):306-12. doi: 10.1177/2168479017731584

Deal LS, DeMuro C, DiBenedetti D, Lewis S. Development of the observable behaviors of autism spectrum disorder scale. Ther Innov Regul Sci. 2017 May 1;51(3):372-9. doi: 10.1177/2168479016680258

Layton JB, Hansen MK, Jakobsen CJ, Kshirsagar AV, Andreasen JJ, Hjortdal VE, Rasmussen BS, Simpson RJ, Brookhart MA, Christiansen CF. Statin initiation and acute kidney injury following elective cardiovascular surgery: a population cohort study in Denmark. Eur J Cardiothorac Surg. 2016 Mar;49(3):995-1000. doi: 10.1093/ejcts/ezv246

Williams V, McLeod L, Nelson L. Advances in the evaluation of longitudinal construct validity of clinical outcome assessments. Ther Innov Regul Sci. 2015 Nov;49(6):805-12. doi: 10.1177/2168479015609103

O'Donohoe P, Lundy JJ, Gnanasakthy A, Greene A. Considerations for requiring subjects to provide a response to electronic patient-reported outcome instruments. Ther Innov Regul Sci. 2015 Nov;49(6):792-6. doi: 10.1177/2168479015609647

Gnanasakthy A, DeMuro C. Overcoming organizational challenges of integrating patient-reported outcomes in oncology clinical trials. Ther Innov Regul Sci. 2015 Oct;49(6):822-30. doi: 10.1177/2168479015608413

Gnanasakthy A, Sadrick A, Eghbal-Ahmadi M, DeMuro C. Promotion of patient-reported outcome label claims based on nonprimary endpoints. Ther Innov Regul Sci. 2014 Sep;48(5):557-63.

Henderson GE, Cadigan RJ, Edwards TP, Conlon I, Nelson AG, Evans JP, Davis AM, Zimmer C, Weiner BJ. Characterizing biobank organizations in the U.S.: results from a national survey. Genome Med. 2013 Jan 25;5(1):3. doi: 10.1186/gm407

Gnanasakthy A, DeMuro-Mercon CJ, Clark MJ, Mordin MM, Thomas S. Role of patient-reported outcome measures in the assessment of central nervous system agents. Ther Innov Regul Sci. 2013;47(5):613-8.

Sharp L, Foll P, Deady S, O'Ceilleachair A, Buicke C, Carsin AE. Where do people with lung cancer die and how is this changing? A population-based study. Irish Med J. 2010 Oct;103(9):262-6.